MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 4.0X26MM 3.5 AND 4.0; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	102040126S
Medical Device Problem Codes	Device Slipped (1584); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2024 the patient underwent a posterior cervical fusion (c2-7) with the screws in question.After the original procedure, on (b)(6) 2024 it was discovered that there was loosening of the c7 puncture point.A revision procedure was scheduled for (b)(6) 2024 to remove the loosened screws and re-insert in another trajectory.The revision procedure was completed successfully.C2-7 crosslinks, set screws, and rods were removed, and c7 (right and left) screws were removed.On the left side of c7, the puncture point was changed and the screw was reinserted.T1 and t2, screws were inserted on right and left.The rod was placed on c2 to t2, and crosslink was placed to terminate the surgery.No further information is available.This report is for a symphony oct system polyaxial screw diameter 4.0 rod, 4.0x26mm 3.5 and 4.0.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.B3: event occurred on an unknown date in (b)(6) 2024.D2: additional procode: nkg.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: d4: expiration date added.H3, h4, h6: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history review (dhr): a manufacturing record evaluation was performed for the finished device product code:102040126s lot no:347081 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 14-jul-2022 manufacturing site: jabil le locle expiry date: 31-may-2027 h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 4.0X26MM 3.5 AND 4.0
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19081288
• Report Number: 1526439-2024-01269
• Device Sequence Number: 20903766
• Product Code: KWP
• UDI-Device Identifier: 10705034529042
• UDI-Public: (01)10705034529042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 102040126S
• Device Lot Number: 347081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 PLY SCRW 4.0X26.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown